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Denali Aims for Early 2025 Hunter Syndrome BLA

[ Price : $8.95]

Denali Therapeutics plans to submit a BLA early next year that will seek accelerated approval for DNL310 (tividenofusp alfa) and i...

Guidance on BIMO Data Technical Specifications

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FDA releases a guidance entitled Bioresearch Monitoring Technical Conformance Guide Technical Specifications Document that provid...

Otsuka Pharmaceutical FDA-483 Released

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FDA releases the form FDA-483 with five observations from an inspection at the Otsuka Pharmaceutical second factory in Tokushima, ...

FDA Clears Embecta Disposable Insulin Patch Pump

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FDA clears an Embecta 510(k) for its Disposable Patch Pump for Insulin Delivery, intended for use by adults who require insulin to...

ADHD Digital Therapy Devices Put Into Class 2

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Federal Register notice: FDA classifies certain digital therapy devices for attention deficit hyperactivity disorder into Class 2.

Class 2 for Neuromuscular Tongue Muscle Stimulators

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Federal Register notice: FDA classifies neuromuscular tongue muscle stimulators and their use for reducing snoring and obstructive...

Feedback Sought on Model-Informed Drug Development

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CDER and CBER seek input to help advance the agencys model-informed drug development program.

FDA Authorizes Updated Novavax Covid Vaccine

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FDA grants an emergency use authorization for an updated version of Novavaxs Covid-19 vaccine that more closely targets currently ...

Emergent Bio Wins Mpox Vaccine Approval

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FDA approves an Emergent BioSolutions supplemental BLA for an expanded indication ACAM2000, (smallpox and mpox vaccine, live) to i...

FDA Backs CellProthera Cell Therapy Phase 3 Study

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CellProthera says a recent FDA meeting led to their alignment on a planned pivotal Phase 3 trial design for its ProtheraCytes cell...